Image via Wikipedia Okay I'm not going to write an article about woulda coulda shoulda. But Jazz was shot down today heavily by the FDA by a vote of 20-No 2 Yes. Mostly due to concerns over abuse of the JZP-6 sodium oxybate drug which is highly similar to GHB. GHB was banned altogether by the FDA in 1990 and is viewed to have no medical benefits in the US.
Showing posts with label Gamma-Hydroxybutyric acid. Show all posts
Showing posts with label Gamma-Hydroxybutyric acid. Show all posts
8/20/10
Jazz Pharma rejected for Fibramyalgia Drug by FDA vote 20-2
Image via Wikipedia Okay I'm not going to write an article about woulda coulda shoulda. But Jazz was shot down today heavily by the FDA by a vote of 20-No 2 Yes. Mostly due to concerns over abuse of the JZP-6 sodium oxybate drug which is highly similar to GHB. GHB was banned altogether by the FDA in 1990 and is viewed to have no medical benefits in the US.
8/18/10
FDA staff: Jazz drug works, risk plan an issue
By Lisa Richwine
WASHINGTON | Wed Aug 18, 2010 11:23am EDT
(Reuters) - U.S. drug reviewers said a Jazz Pharmaceuticals Inc medicine helped patients with the pain disorder fibromyalgia, sending shares up 14 percent Wednesday on hopes an approval could sharply boost the company's sales.
Food and Drug Administration staff said the drug, sodium oxybate or JZP-6, was effective. But they also questioned if the company's proposed safeguards would adequately prevent improper use. The medicine contains an ingredient notoriously abused as a "date rape" drug.
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